Actively Recruiting

Age: 22Years +
All Genders
ID06682923

Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients

Led by MolecuLight Inc. · Updated on 2024-11-12

72

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the MolecuLightDX device for measuring surface wounds in patients, comparing its accuracy to the standard ruler method. The goal is to assess how closely the device's wound measurements (area, length, and width) match expert panel reference standards. This observational study focuses on wounds such as diabetic foot ulcers, venous, arterial, and pressure ulcers in adults aged over 22 years. Participants will have their wounds measured using both the MolecuLightDX device, which captures fluorescence images, and the traditional ruler method. The device does not change the participant's usual wound care treatment. Measurements will be taken manually and automatically by the device, and the study will last up to six months to observe and compare measurement accuracy and consistency. During the study, participants will undergo wound assessments where data such as wound area, length, and width will be recorded using both methods. Researchers will monitor measurement errors and variability among users over time. Participants must be available and willing to follow study procedures for the full duration. The main outcome is the percent error in wound area measurement by the device compared to expert standards, with additional evaluation of measurement consistency.

CONDITIONS

Brief Title

MolecuLightDX Measurement Feature Clinical Validation

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to consent
  • Willing to comply with all study procedures and be available for the study duration
  • Male or female, aged over 22 years old
  • Presenting with diabetic foot ulcers, venous, arterial, or pressure ulcers
  • Wound size greater than 0.5 cm2
  • Wound has well-defined borders
Not Eligible

You will not qualify if you...

  • Circumferential wound
  • Wound without clearly defined borders
  • Wound in a difficult to reach or measure location
  • Any contraindication to routine wound care or monitoring
  • Wounds longer than 18.5 cm or wider than 13.5 cm
  • Tunneled or undermined wounds

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 months

Participants undergo wound measurements using both the MolecuLightDX device and the standard ruler method to compare accuracy against expert panel assessments.

Multiple visits over up to 6 months depending on wound monitoring schedule

Trial Site Locations

Total: 2 locations

1

The Mayer Institute

Hamilton, Ontario, Canada, L8R 2R3

Actively Recruiting

2

SHN Research Institute

Scarborough Village, Ontario, Canada, M1E 4B9

Not Yet Recruiting

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Research Team

L

Laura Jones-Donaldson, PhD

H

Hanna Varonina, MSc, CCRP

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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